Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro

Picterus

Status: Enrolling

Conditions: Neonatal Jaundice

Treatments: Device: Picterus Jaundice Pro (JP)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06329843

Intermountain

Details and patient eligibility

About

The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.

Full description

The purpose of this study is to compare serum bilirubin levels with non-invasive bilirubin measurements in neonates during the first 12 to 192 hours of life using the "Picterus Jaundice Pro" smartphone application with a proprietary calibration card placed over the neonate's sternum. We will also validate the accuracy of Picterus Jaundice Pro bilirubin measurements before and after phototherapy treatment.

Enrollment: 500 estimated patients

Sex: All

Ages: 12 to 192 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• the patient is free of skin rash, bruising, or other medical conditions that can interfere with transcutaneous measurement
• (preterm) < = 35 weeks gestational age
• (term) > 35 weeks gestational age
• the patient has not been excluded by PI discretion.

Exclusion criteria

• Neonates will be excluded from participation if all four inclusion criteria listed above are not met.

Trial design

500 participants in 1 patient group

Term-born babies & preterm born babies

Description:

We will collect 300 paired (serum bilirubin and Picterus Jaundice Pro) measurements on eligible neonates \>35 weeks' gestation admitted to a well-baby nursery. Of these, 150 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject \>35 weeks gestation can have up to 5 measurements during the study. We will collect 200 paired (serum bilirubin and Picterus) measurements on eligible neonates \<35 weeks gestation. Of these, 100 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject \<35 weeks gestation can have up to 5 measurements during the study.

Treatment:

Device: Picterus Jaundice Pro (JP)